
[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Notices]               
[Page 8375-8377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe10-109]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0080]

 
Device Improvements to Reduce Unnecessary Radiation Exposure From 
Medical Imaging; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled: ``Device Improvements to Reduce Unnecessary Radiation 
Exposure From Medical Imaging.'' The purpose of this meeting is to 
discuss steps that could be taken by manufacturers of devices used in 
computed tomography (CT) and in fluoroscopy that would help reduce 
unnecessary patient exposure to ionizing radiation during CT and 
fluoroscopic procedures. FDA is seeking input on this topic and 
requests comments on a number of related questions.
    Dates and Time: The public meeting will be held on March 30 and 31, 
2010, from 8 a.m. to 5 p.m. Persons interested in attending and/or 
participating in the meeting must register by 5 p.m. on March 15, 2010. 
Submit written or electronic comments by April 15, 2010.
    Location: The public meeting will be held at the Holiday Inn 
Gaithersburg, 2 Montgomery Village Ave., Gaithersburg, MD 20879. The 
meeting will not be videotaped or webcast.
    Contact Person: Simon Choi, Food and Drug Administration, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, rm. 5400, Silver Spring, MD 20993-
0002, 301-796-5426, e-mail: simon.choi@fda.hhs.gov.
    Registration: If you wish to attend the public meeting, you must 
register by e-mailing CDRHimaginginitiative@fda.hhs.gov. Provide 
complete contact information for each attendee, including name, title, 
company or organization, address, e-mail, and telephone number. 
Registration requests must be received by March 15, 2010.
    If you wish to make an oral presentation during any of the sessions 
at the meeting (see section II of this document, Public Meeting), you 
must indicate this at the time of registration. FDA has included 
specific questions for comment in section III of this document, 
Questions for Comment. You should also identify the session(s) during 
which you would like to present, as well as the question(s) you would 
like to address in each session. In order to keep each session focused 
on the topic at hand, presentations given during each session should 
address only the topic specified for that session. FDA will do its best 
to accommodate requests to speak. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and to request time for a joint presentation. FDA will 
determine the amount of time allotted to each presenter and the 
approximate time that each oral presentation is scheduled to begin.
    If you would like to participate in any of the four planned 
roundtable discussions (see section II of this document, Public 
Meeting), you must indicate this interest at the time of registration, 
and also submit a brief statement that describes your experience with 
CT or fluoroscopic devices. FDA is seeking participants interested in 
engaging in one of four wrap-up roundtable discussions related to the 
presentations given during each of the earlier sessions of the meeting. 
Each roundtable discussion will include no more than 10 nonFDA 
participants. Only one participant from an organization or company will 
be assigned to each discussion group. FDA will attempt to have a range 
of constituencies represented in each discussion group. Others in 
attendance at the public meeting will have an opportunity to listen to 
each roundtable discussion.
    Registration is free and will be on a first-come, first-served 
basis. Early registration is recommended because seating is limited. 
FDA may limit the number of participants from each organization based 
on space limitations. Registrants will receive confirmation once they 
have been accepted. Onsite registration on the day of the public 
meeting will be provided on a space-available basis beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Simon Choi at 301-796-5426, simon.choi@fda.hhs.gov at least 7 
days in advance of the meeting.
    Comments: FDA is holding this public meeting to obtain information 
on a number of questions regarding steps manufacturers of CT and 
fluoroscopic devices could take to help reduce unnecessary patient 
exposure to ionizing radiation from these medical imaging modalities. 
The deadline for submitting comments related to this public meeting is 
April 15, 2010.
    Regardless of attendance at the public meeting, interested persons 
may submit written or electronic comments. Submit written comments to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. In addition, when

[[Page 8376]]

responding to specific questions as outlined in section III of this 
document, please identify the question you are addressing. Received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

I. Background

    Like all medical procedures, medical imaging that uses ionizing 
radiation presents both benefits and risks. Medical imaging has led to 
improvements in the diagnosis and treatment of numerous medical 
conditions. At the same time, exposure to ionizing radiation may 
elevate patients' lifetime risk of developing cancer. Overexposure to 
ionizing radiation can also cause injuries in the short-term such as 
skin burns and hair loss. In an effort to reduce these risks, FDA's 
Center for Devices and Radiological Health (CDRH) recently announced 
the Initiative to Reduce Unnecessary Radiation Exposure from Medical 
Imaging (see http://www.fda.gov/Radiation-EmittingProducts/
RadiationSafety/RadiationDoseReduction/UCM199904 for more information).
    FDA is currently exploring steps that manufacturers of CT and 
fluoroscopic devices could take to reduce unnecessary radiation 
exposure through improved product design, enhanced labeling, or 
improved instructions and training for equipment use and quality 
assurance at medical imaging facilities.

II. Public Meeting

    The objective of this public meeting is to receive public input on 
steps manufacturers of CT and fluoroscopic devices should take to help 
reduce unnecessary patient exposure to ionizing radiation from these 
medical imaging modalities.
    The meeting will be held over the course of 2 days. Each day will 
be divided into two sessions. Day 1 will focus on equipment features 
that manufacturers should incorporate into CT scanners (morning 
session) and fluoroscopes (afternoon session). Day 2 will focus on 
steps manufacturers should take to improve training of individuals who 
use these devices (morning session) and steps to improve quality 
assurance at medical imaging facilities with respect to these two 
modalities (afternoon session).
    During each session, members of the public may present oral 
comments related to the topic of that session. Specific questions for 
comment are listed in section III of this document, Questions for 
Comment. Individuals who are interested in giving an oral presentation 
during any of the sessions must indicate this interest at the time of 
registration and must also identify the session(s) at which they would 
like to present (see Registration). In order to keep each session 
focused on the topic at hand, each oral presentation should address 
only the topic specified for that session. Commentators are free to 
submit written comments on any topic(s) to the open docket (see 
Comments). FDA will schedule speakers for each session as time permits.
    To close each of the four sessions, FDA will hold a roundtable 
discussion between FDA staff and selected participants representing a 
range of constituencies (for more information about participating in 
the roundtable discussion, see Registration). The participants in each 
roundtable discussion will remark on the presentations given during the 
session, engage in a dialogue with each other and FDA staff, and 
provide closing thoughts on the session. Roundtable participants will 
not be asked to develop consensus opinions during the discussion, but 
rather to provide their individual perspectives. Others in attendance 
at the meeting will have an opportunity to listen to each roundtable 
discussion.
    In advance of the meeting, additional information, including a 
meeting agenda with a speakers' schedule for each session, will be made 
available on the Internet. This information will be placed on file in 
the public docket (docket number found in brackets in the heading of 
this document), which is available at http://www.regulations.gov. This 
information will also be available at http://www.fda.gov/
MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the 
appropriate meeting from the list).

III. Questions for Comment

A. Device-Specific Elements: Equipment Features, Labeling, and 
Premarket Submission Requirements

    Note: The questions in the following paragraphs are relevant to 
both CT and fluoroscopic devices. Please clearly indicate in your 
response which modality you are discussing. Additionally, while the 
questions are worded broadly, please feel free to include elements in 
your response that are specific to particular types of procedures 
(e.g., multi-phase contrast-enhanced CT examinations, perfusion 
studies, etc.) or devices (e.g., multidetector CT devices that allow 
very thin slices, etc.).
    1. What hardware and software features should manufacturers build 
into CT and fluoroscopic devices in order to reduce unnecessary 
exposure to ionizing radiation during each imaging exam, and in order 
to reduce what may be inappropriate prescription of imaging exams? 
Should manufacturers incorporate special provisions for pediatric and 
female patients?
    2. Should manufacturers incorporate access controls and audit 
capabilities into CT and fluoroscopic equipment in order to identify 
the user(s) of the device during any particular exam, and to identify 
those responsible for creating and changing imaging protocols and 
exposure settings? If so, why, and what access controls and audit 
capabilities should be incorporated? If not, why not?
    3. Should manufacturers incorporate warnings, alerts, lockouts, or 
overrides into CT and fluoroscopic equipment that would inform users 
and require confirmation or possibly procedure modification during an 
imaging session in which the patient could be exposed to high levels of 
radiation? If so, why, and what warnings, alerts, lockouts, or 
overrides should be incorporated? If not, why not?
    4. Should manufacturers set default imaging protocols for CT and 
fluoroscopic procedures so that they incorporate the ALARA concept 
(maintaining dose As Low As Reasonably Achievable) and utilize or 
provide for incorporation of diagnostic reference levels into CT and 
fluoroscopic devices? If so, why and how? If not, why not?
    5. Should manufacturers incorporate exam referral criteria into CT 
and fluoroscopy equipment to allow users to check the appropriateness 
of an imaging exam before it is initiated or flag an exam after it is 
done? If so, why and how? If not, why not?
    6. Should manufacturers incorporate into CT and fluoroscopic 
equipment features to ensure that exposure settings, imaging protocols, 
and metrics of body dose and peak skin dose are displayed to the 
operator(s) of the equipment and recorded for physician review? If so, 
why and how? If not, why not?
    7. Should manufacturers incorporate features into CT and 
fluoroscopic equipment to facilitate transmission of technique 
parameters, imaging protocols, and dose metrics to a patient's imaging 
record, an electronic health record, or other database? If so, why and 
how? If not, why not?
    8. Should manufacturers take steps to improve the labeling of CT 
and fluoroscopic devices, such as including more information about 
radiation exposure, including more information

[[Page 8377]]

about the clinical applications of the device that have been shown to 
be safe and effective, improving instructions for use for each distinct 
clinical application, and including a comprehensive quality control 
manual? If so, why and how? If not, why not?
    9. Should manufacturers submit more data to FDA as part of their 
premarket submissions for approval or clearance of CT and fluoroscopic 
devices, related to the safety and effectiveness of these devices 
(e.g., data demonstrating the safety and effectiveness of the device 
specific to each distinct clinical indication, or clinical data 
demonstrating the benefit of relatively high-dose procedures, for 
example, those with peak skin doses exceeding 1 Gy)? If so, why, and 
what data should be submitted? If not, why not?
    10. Should manufacturers submit technical data to FDA as part of 
their premarket submissions for approval or clearance of CT and 
fluoroscopic devices, demonstrating dose reduction and image quality 
claims? If so, why, and what data should be submitted? If not, why not?
    11. In addition to the already-required indications for use 
statement, should manufacturers of CT and fluoroscopic devices submit 
to FDA as part of their premarket submissions a list of common clinical 
applications for which the device could be used (such as those 
requiring special software supported by the device) and the appropriate 
demographics of the likely patient populations for those exams? If so, 
why, and what level of information should be submitted? If not, why 
not?
    12. What changes should manufacturers make to CT and fluoroscopic 
devices currently on the market in order to reduce unnecessary patient 
exposure to ionizing radiation?

B. User Training

    1. Should manufacturers provide training to medical imaging 
equipment users to ensure adequate understanding of equipment 
capabilities, operating principles for the technology, general 
information about optimizing patient dose and image quality, and 
specific dose-reduction equipment features? If so, why, and what 
training should be provided? If not, why not?
    2. If manufacturers provide such training, which personnel should 
receive it to ensure proper use of medical imaging equipment and dose 
reduction features? In your response, please consider radiologic 
technologists or technologists in other specialties as well as 
physicians in all medical specialties who operate fluoroscopic 
equipment.
    3. If manufacturers provide such training, how, when, and how often 
should it be delivered so that it is easily and effectively implemented 
at imaging facilities? For example, for software upgrades that affect 
dose, should training be performed at each site as well as training at 
the time of equipment installation?

C. Quality Assurance Measures

    1. Should manufacturers provide quality assurance (QA) instructions 
and standard operating procedures to medical imaging facilities and 
users of CT and fluoroscopic devices? If so, why, and what instructions 
should be provided? If not, why not?
    2. Should manufacturers provide training on quality assurance 
practices? If so, why, what type of training should be provided, and to 
which personnel? If not, why not?

D. Evaluation

    1. What tools and metrics should FDA, in collaboration with others 
in the Federal Government and the healthcare professional community, 
use to evaluate the impact of efforts to reduce unnecessary radiation 
exposure from medical imaging?

IV. Transcripts

    Transcripts of the public meeting may be requested in writing from 
the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public meeting at a cost of 10 
cents per page. A transcript of the public meeting will be available on 
the Internet at http://www.regulations.gov.

    Dated: February 18, 2010.
Jeffrey Shuren,
Director, Center for Devices and Radiological Health.
[FR Doc. 2010-3674 Filed 2-23-10; 8:45 am]
BILLING CODE 4160-01-S

